Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation

This study has been completed.

Sponsor:

Information provided by:

Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT00459797

First received: April 12, 2007

Last updated: April 20, 2009

Last verified: April 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 12, 2007

Last Updated Date

April 20, 2009

Start Date ^ICMJE

April 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to intubation (seconds) [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Time to intubation (seconds)

Change History

Complete list of historical versions of study NCT00459797 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Ease of intubation [ Time Frame: after intubation ] [ Designated as safety issue: No ]
Number of intubation attempts per group [ Time Frame: after intubation ] [ Designated as safety issue: No ]
Incidence of trauma in each group [ Time Frame: after intubation ] [ Designated as safety issue: No ]
Number of failures to intubate per group [ Time Frame: after intubation ] [ Designated as safety issue: No ]
Use of external laryngeal pressure per group [ Time Frame: after intubation ] [ Designated as safety issue: No ]
Laryngoscopic grade distribution in each group [ Time Frame: after intubation ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Ease of intubation
Number of intubation attempts per group
Incidence of trauma in each group
Number of failures to intubate per group
Use of external laryngeal pressure per group
Laryngoscopic grade distribution in each group

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation

Official Title ^ICMJE

Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation

Brief Summary

Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the conventional (reusable) GlideScope videolaryngoscope or the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Device: Conventional (reusable) Glidescope
Device: Single-use Glidescope videolaryngoscope

Study Arm (s)

Active Comparator: Conventional Glidescope
Intervention: Device: Conventional (reusable) Glidescope
Experimental: Single-use Glidescope
Intervention: Device: Single-use Glidescope videolaryngoscope

Publications *

Jones PM, Turkstra TP, Armstrong KP, Armstrong PM, Harle CC. Comparison of a single-use GlideScope Cobalt videolaryngoscope with a conventional GlideScope for orotracheal intubation. Can J Anaesth. 2010 Jan;57(1):18-23. Epub 2009 Oct 31.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Any patient who is ≥ 18 yrs. coming for elective surgery.
Endotracheal tube is indicated for the procedure in the opinion of the attending anesthesiologist.
Any operator who has performed ≥ 10 GlideScope intubations.

Exclusion Criteria:

Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
Any patient with cervical spine abnormalities.
Any patients with known or probable difficult airways (this rare occurrence is unlikely to be evenly distributed between the groups and could skew the data).
Any patient requiring rapid sequence induction.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00459797

Other Study ID Numbers ^ICMJE

R-07-040, 13025

Has Data Monitoring Committee

Responsible Party

Philip Jones, LHSC

Study Sponsor ^ICMJE

Lawson Health Research Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Philip M Jones, MD

London Health Sciences Centre

Information Provided By

Lawson Health Research Institute

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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